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Dublin, Ireland, 05 January 2021 - Ovoca Bio plc (LSE: OVB; ISE: OVXA), a biopharmaceutical company with a focus on women's health, today announces that a new Marketing Authorisation ("MA") application for BP-101, a novel synthetic peptide administered through a nasal spray, was filed by its subsidiary, IVIX LLC ("IVIX"), with the Russian Ministry of Health (the "Minzdrav") on 30 December 2020.
IVIX submitted the BP-101 MA application for the treatment of hypoactive sexual desire disorder (or "HSDD"), a condition characterized by a distressing lack or loss of sexual desire, in premenopausal women. The MA application is based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study conducted in Russia, which establish the safety and efficacy of BP-101 in the proposed indication.
